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| Name | Class |
|---|---|
| Ministry of Health and Medical Education | UNKNOWN |
| Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran | UNKNOWN |
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This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIK Intervention plus routine treatment | Experimental | Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion |
|
| Control | Active Comparator | Patients who receive routine treatments only (chemotherapy, radiation therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine-induced killer cell | Biological | Immune-cell therapy with CIK cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of administering CIK cells plus chemotherapy | Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion | one month post infusion |
| Progression-free Survival (PFS) | The time from treatment initiation day to first documented progressive disease or death due to disease. | 2 years |
| Time to progression (TTP) | the time from randomization until cancer progression, not including death. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The length of time that the patients are still alive at a defined period of time after treatment | 2 years |
| Patient quality of life | Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naser Ahmadbeigi, Ph.D | Contact | +9821-82415103 | n-ahmadbeigi@sina.tums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Naser Ahmadbeigi, Ph.D | Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences | Recruiting | Tehran | Iran |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Chemotherapy AND/OR Radiation Therapy | Other | Routine treatments for colon cancer patients according to their stage |
|
| each 3 months for 2 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |